The following data is part of a premarket notification filed by Kao Ying Industrial Co., Ltd. with the FDA for Patient Examination Glove (vinyl).
| Device ID | K892565 |
| 510k Number | K892565 |
| Device Name: | PATIENT EXAMINATION GLOVE (VINYL) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | KAO YING INDUSTRIAL CO., LTD. NO. 49, LANE 110 FUN JEN RD. FUN SHAN CITY, KAOHSIUNG Hsien, Taiwan R.o.c., TW |
| Contact | Young |
| Correspondent | Young KAO YING INDUSTRIAL CO., LTD. NO. 49, LANE 110 FUN JEN RD. FUN SHAN CITY, KAOHSIUNG Hsien, Taiwan R.o.c., TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-08-09 |